Schedule I is the most restrictive category for controlled substances, including those drugs defined as having a high potential for abuse, no currently accepted medical use, and a lack of accepted safety for use under medical supervision.

The lawsuit was brought by a coalition of organizations and individual patients, including Americans for Safe Access, the Coalition to Reschedule Cannabis, and Patients out of Time. Since California became the first U.S. state to pass and implement a medical marijuana law in 1996, 17 other states and the District of Columbia have followed suit by passing legislation or voter initiatives that allow certain patients to legally access marijuana.

According to the appeals court, the DEA was following its own rules when it claimed that petitioners for rescheduling marijuana had failed to provide "adequate and well-controlled studies proving efficacy." While the petitioners had provided peer-reviewed research as to the medical benefits of marijuana, the DEA requires studies more in line with the specific trials required by the FDA.

“We’re stuck in a Catch-22 – the DEA is saying that marijuana needs FDA approval to be removed from Schedule I, but at the same time they are obstructing that very research,” said Tamar Todd, senior staff attorney for the Drug Policy Alliance. “While there is a plethora of scientific evidence establishing marijuana's safety and efficacy, the specific clinical trials necessary to gain FDA approval have long been obstructed by the federal government itself.”

Largely out of public view, for more than four decades the federal government’s National Institute on Drug Abuse (NIDA) and the DEA have obstructed medical marijuana research by maintaining a government monopoly on the supply of marijuana that can legally be used in research. Marijuana remains the only Schedule I drug that DEA prohibits from being produced by private laboratories for scientific research. Although DEA has licensed multiple privately-funded manufacturers of all other Schedule I drugs, it permits just one facility, located at the University of Mississippi, to produce marijuana for research purposes. This facility, under contract with NIDA, holds a literal monopoly on the supply of marijuana available to scientists, including researchers seeking to conduct FDA-approved studies of the plant's medical properties – studies that, of course, squarely conflict with NIDA's mission to study drug abuse. The DEA, for its part, protects NIDA’s monopoly by refusing to license other qualified manufacturers.